FDA Adverse Event
Injury
Summary report: N
NARVAL CC ORTHESE MRD
MDR report key: 5695963
·
Received June 2, 2016
Report
- Report Number
- 3004604967-2016-00580
- Event Type
- Injury
- Date Received
- June 2, 2016
- Date of Event
- May 5, 2016
- Report Date
- June 2, 2016
- Manufacturer
- RESMED SAS
- Product Code
- LQZ
- PMA / PMN Number
- K113201
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, THEREFORE, RESMED IS UNABLE TO DETERMINE IF A DEVICE FAULT CONTRIBUTED TO THE INCIDENT. RESMED IS IN COMMUNICATION WITH THE REPORTER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT DETAILS AND REQUESTED THE UNIT BE RETURNED SO THAT AN EXTENSIVE ENGINEERING INVESTIGATION CAN BE PERFORMED. RESMED REFERENCE #: (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO RESMED (B)(4) THAT A NARVAL CC MANDIBULAR REPOSITIONING DEVICE FRACTURED A PATIENT'S LOWER ANTERIOR TOOTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350408 | NARVAL CC ORTHESE MRD | DEVICE, JAW REPOSITIONING | LQZ | RESMED SAS | 200002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |